UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062929 |
|---|---|
| Receipt number | R000072052 |
| Scientific Title | Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/15 13:55:16 |
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Basic information
Public title
Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity
Acronym
Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity
Scientific Title
Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity
Scientific Title:Acronym
Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of an intimate female partner's presence and involvement, including visual, auditory, and tactile stimuli, on pain sensitivity among healthy Japanese adult men who have been in a relationship with their partner for at least three months.
Basic objectives2
Others
Basic objectives -Others
This study examines the effects of a partner's presence and involvement on pain sensitivity among healthy Japanese adult men who have had a partner for at least three months.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Intensity Using a Visual Analog Scale
Key secondary outcomes
Emotional Assessment Using the POMS-II Short Form
Japanese Version of Experiences in Close Relationships
Salivary Chromogranin A
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Partner is present.
Interventions/Control_2
Partner is not present.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Individuals who have fully understood the nature of the study and have provided both verbal and written informed consent
2) Healthy Japanese adult males aged 18 to 29 years on the day of the study
3) Individuals with no current pain
4) Non smokers
5) Individuals who are obtaining sufficient sleep
6) Individuals who have not engaged in more than 4 hours of exercise on either the day preceding the study or the day before that
7) Individuals with no history or current presence of conditions such as autonomic nervous system disorders, cardiovascular disease, central or peripheral nervous system disorders, or conditions involving sensory or dermatological abnormalities
8) Individuals who have not undergone any form of pharmacological treatment-including oral medication, transdermal patches, or injections such as analgesics or agents affecting the central nervous system, within the three days prior to the start of the study
9) Individuals who, at the time of enrollment, have a partner with whom they have been in a relationship for at least three months
Key exclusion criteria
1) Individuals with findings that can be judged to be clearly abnormal immediately prior to or during the study
2) Individuals whom the principal investigator determines are unable to maintain a stable mental state or are at risk of becoming unstable
3) Individuals with trauma, skin abnormalities, physical abnormalities, or other conditions at the time of the study
4) Individuals currently taking any analgesics or medications that affect the central nervous system
5) Any other individuals deemed to present difficulties in conducting this study or for whom there is a risk of such difficulties
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa 212-0054 Japan
TEL
044-587-3520
kakeda-t@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa, Japan
TEL
+81-44-587-3520
Homepage URL
kakeda-t@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Riku Yokoyama
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee in Kawasaki City College of Nursing
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa, Japan
Tel
+81-44-587-3500
ethics@kawasaki-cn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072052
